Silsol 6035

Description

Amorphisation of crystalline APIs for better bioavailability/solubility.

Our SILSOL^® silica active ingredient delivery technology combines Grace’s extensive expertise in mesoporous silica gel, novel application methods, and patented technologies to accelerate the screening and development of solubility enhancing solid dispersions, with the added benefit of doing so with compendial, scalable, and available silicas.

Grace’s SILSOL^® silica active ingredient delivery technology offers several critical benefits:

• Enhanced bioavailability through delivery of the amorphous form of active ingredients
• Sustained stability from amorphous solid dispersions that prevent crystallization/re-crystallization
• Pharmacopoeia acceptance of our cGMP manufactured silica that conforms to global monographs
• Scalable cGMP excipient manufacturing from grams to tons quantities
• EU Commission Regulation No. 231/2012 (E 551materials listed on the FDA inactive ingredient database (IID)
• Suitable for NCE, life cycle management, reformulations, and repositioning
• Applicable to a broad range of compounds (including all BCS2 poorly soluble drugs)
• Easy and cost-effective introduction into established manufacturing units
• Generates stable formulations, including towards polymer-based ASD’s by reducing the water activity

Compared to other bioavailability enhancing techniques such as particle size reduction, complexation, lipid-based systems, and polymer-based solid dispersions, our SILSOL^® silica technology introduces techniques that are easier to screen and work in combination with existing technologies to improve usage and stability, thereby reducing the time needed to scale up.

Grace’s SILSOL^® silica active ingredient delivery technology is used with solvent impregnation to create amorphous solid dispersions. Due to our vast expertise in particle design, Grace can modify the pore size and surface characteristics of silica to accommodate various API molecules. The net result is enhanced bioavailability with improved stability.